FDA Drugs recall ·
evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%… recall
- Recall number
- D-0060-2027
- Date
- (initiated September 10, 2026)
- Company / brand
- Pritam International Private Limited
Khasra No. 138, Raipur Industrial Area, Haridwar, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 389,880 tubes
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3
Why was it recalled?
CGMP Deviations.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# LWP250038760606, Exp Date: 08/05/2027; Lot# LWP250045152409B, Exp Date: 10/07/2027; Lot# LWP250046862110B, Exp Date: 11/15/2027; Lot# LWP250047640511C, Exp Date: 12/15/2027; Lot# LWP250051172312B, Exp Date: 01/27/2028; Lot# LWP260052241401A, Exp Date: 03/20/2028; Lot# LWP260055532003, Exp Date: 04/12/2028.
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0060-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.